EP 3352790 A1 20180801 - METHOD OF PREPARING A THERAPEUTIC PROTEIN FORMULATION AND ANTIBODY FORMULATION PRODUCED BY SUCH A METHOD
Title (en)
METHOD OF PREPARING A THERAPEUTIC PROTEIN FORMULATION AND ANTIBODY FORMULATION PRODUCED BY SUCH A METHOD
Title (de)
VERFAHREN ZUR HERSTELLUNG EINER THERAPEUTISCHEN PROTEINFORMULIERUNG UND NACH DIESEM VERFAHREN HERGESTELLTE ANTIKÖRPERFORMULIERUNG
Title (fr)
PROCÉDÉ DE PRÉPARATION D'UNE FORMULATION DE PROTÉINE THÉRAPEUTIQUE ET FORMULATION D'ANTICORPS PRODUITE PAR UN TEL PROCÉDÉ
Publication
Application
Priority
- US 201562222067 P 20150922
- IB 2016055355 W 20160908
Abstract (en)
[origin: WO2017051273A1] The invention relates to a method of preparing a protein formulation including a therapeutic protein, the method comprising the steps of: providing a solution comprising said protein; concentrating the protein in the solution by a first ultra-filtration step; diafiltering the solution with a diafiltration buffer including at least one first excipient, whereby a retentate is obtained comprising the protein and the first excipient; further concentrating the protein in the retentate by a second ultra-filtration step; and adding at least one final excipient, whereby the protein formulation with a desired protein concentration is obtained. According to the invention, the method further comprises, before the second ultra- filtration step, adding a second excipient to the retentate obtained from the diafiltration step. The invention is also directed to antibody formulations produced by the foregoing method.
IPC 8 full level
A61K 39/395 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); G01N 33/68 (2006.01)
CPC (source: EP IL KR US)
A61K 9/08 (2013.01 - EP KR); A61K 39/395 (2013.01 - IL); A61K 39/39591 (2013.01 - EP KR US); A61K 47/18 (2013.01 - IL); A61K 47/183 (2013.01 - EP KR US); A61K 47/22 (2013.01 - US); A61K 47/26 (2013.01 - IL KR US); C07K 1/34 (2013.01 - EP US); C07K 16/2866 (2013.01 - EP US); G01N 33/68 (2013.01 - IL); C07K 2317/94 (2013.01 - EP KR)
Citation (search report)
See references of WO 2017051273A1
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated extension state (EPC)
BA ME
DOCDB simple family (publication)
WO 2017051273 A1 20170330; AU 2016329034 A1 20180315; AU 2016329034 B2 20190523; CA 2999118 A1 20170330; CA 2999118 C 20220614; CN 108025072 A 20180511; EP 3352790 A1 20180801; HK 1255006 A1 20190802; IL 258311 A 20180531; IL 258311 B 20210429; JP 2017095440 A 20170601; JP 6925111 B2 20210825; KR 20180037056 A 20180410; KR 20200035496 A 20200403; MX 2018003298 A 20180620; RU 2018110145 A 20191023; RU 2018110145 A3 20200210; US 2023134160 A1 20230504
DOCDB simple family (application)
IB 2016055355 W 20160908; AU 2016329034 A 20160908; CA 2999118 A 20160908; CN 201680054397 A 20160908; EP 16774987 A 20160908; HK 18114122 A 20181106; IL 25831118 A 20180322; JP 2016181594 A 20160916; KR 20187007855 A 20160908; KR 20207008879 A 20160908; MX 2018003298 A 20160908; RU 2018110145 A 20160908; US 201615761777 A 20160908